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Novel Epidermal Recording and Detection of Seizures (NERDS)

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ClinicalTrials.gov Identifier: NCT02451618
Recruitment Status : Terminated (Trial was discontinued due to inadequate signal from study eeg leads.)
First Posted : May 22, 2015
Last Update Posted : September 7, 2018
Sponsor:
Collaborator:
The Gerber Foundation
Information provided by (Responsible Party):
M J Harbert, Sharp HealthCare

Brief Summary:
For any newborn that exhibits possible seizure activity or has altered mental status of unknown etiology, continuous bedside EEG recording is the standard of care to detect subclinical seizure activity. The experimental aspect of this study will be the application of test electrodes (EES or EKG) to evaluate if the electrodes can be used to produce a continuous bedside recording of brain activity in the same manner as an EEG recording, while ideally producing less irritation of newborn skin than conventional EEG electrodes.

Condition or disease
Seizures Encephalopathy Asphyxiated Newborn

Detailed Description:

Infants admitted to our NICU that require a standard EEG for clinical diagnosis will be approached for consent to test one of two new methods of EEG recording. Patients will be randomized to the new epidermal electronic system (EES) or the a hydrogel EKG electrode. All patients will continue to receive the standard of care EEG monitoring.

EES is slim new temporary tattoo technology that can easily be applied to the skin without requiring a technician or scrubbing and preparation as with standard EEG lead. The hydrogel EKG are FDA approved leads normally used to detect cardiac rhythm.

Specific Aims:

  1. To compare the rate of detection of neonatal seizures between a new method of recording electrical brain rhythms (EES or EKG) and the current standard of care (EEG, or electroencephalography.)
  2. To compare characterization of electrical brain activity between EES or EKG and EEG in the neonate.

Study Type : Observational
Actual Enrollment : 13 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Pilot Study of Seizure Detection in Neonates Using Multimodal Temporary Epidermal Electronics
Actual Study Start Date : January 27, 2015
Actual Primary Completion Date : November 3, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Seizures

Group/Cohort
Epidermal Electronic System
EES, wireless tattoo electrode
Hydrogel electrode
EKG electrode, looking at hairline placement of electrodes.



Primary Outcome Measures :
  1. Seizure detection [ Time Frame: 24 hours ]
    Seizures detected by study electrodes will be compared to seizures detected on conventional EEG recording.


Secondary Outcome Measures :
  1. EEG characterization [ Time Frame: 24 hours ]
    Compare quality of brain activity with study leads vs standard leads

  2. Skin integrity from standard EEG vs study electrodes [ Time Frame: 24 hours ]
    Photographs will be taken to compare skin integrity after each electrode use.

  3. Hair removal from standard EEG vs study electrodes [ Time Frame: 24 hours ]
    If hair removal is necessary for study electrode placement.


Other Outcome Measures:
  1. Apgar scores [ Time Frame: Birth to 10 minutes of life ]
    Apgars at 1, 5, 10, 15, and 20 minutes of life if applicable

  2. Subject received hypothermia treatment within 6 hours of life [ Time Frame: Within 6 hours of life for 72 hours duration ]
  3. Cause of seizure if known [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 10 days. ]
    Date and time of seizures and etiology

  4. Anticonvulsant medication(s) subject received [ Time Frame: Participants will be followed for the duration of hospital stay, an average of 10 days. ]
    Phenobarbital, Levetiracetam, Phosphenytoin, Versed, Blinded Study Drug, Other

  5. Gestational age [ Time Frame: At birth ]


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any newborn admitted to the NICU that requires an EEG for clinical care. Must be less than or equal to 44 weeks corrected gestational age.
Criteria

Inclusion Criteria:

  • Hospitalized neonates who already require continuous EEG recording for clinical care
  • Parents signed informed consent
  • CGA 44 weeks or less

Exclusion Criteria:

  • Patient is moribund

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02451618


Locations
United States, California
Sharp Mary Birch Hospital for Women and Newborns
San Diego, California, United States, 92123
Sponsors and Collaborators
Sharp HealthCare
The Gerber Foundation
Investigators
Principal Investigator: Mary J Harbert, MD Sharp Mary Birch Hospital for Women & Newborns

Publications:
Volpe JJ. Neonatal Seizures in Neurology of the Newborn, 4th ed. Philadelphia: WB Sanders, 2001: 178-214.

Responsible Party: M J Harbert, Director of Neonatal Neurology, Sharp HealthCare
ClinicalTrials.gov Identifier: NCT02451618     History of Changes
Other Study ID Numbers: Epidermal Electronics
First Posted: May 22, 2015    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018

Keywords provided by M J Harbert, Sharp HealthCare:
Perinatal Depression

Additional relevant MeSH terms:
Seizures
Brain Diseases
Epilepsy
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms